Apparatus and method for fixation of vascular grafts

ABSTRACT

An apparatus for facilitating securement of a vascular graft within a blood vessel, includes a shaft dimensioned for passage within a blood vessel and having an expansion member movable between a contracted condition and an expanded condition and a fastener array comprising at least one fastener disposed about a peripheral portion of the expansion member. The one fastener is deployable into a wall of the blood vessel upon movement of the expansion member to the expanded condition thereof, to thereby engage the vascular graft to secure the vascular graft to a wall of the blood vessel. The fastener array preferably includes a plurality of fasteners. The fasteners may be operatively connected to each other and releasably secured to the peripheral portion of the expansion member.

FIELD OF INVENTION

The present invention relates generally to systems and methodologies forsecuring a graft to a body vessel, and, more particularly, to anintralumenal surgical apparatus and associated method of use forfacilitating introduction and securement of a vascular graft prosthesiswithin a blood vessel.

BACKGROUND OF THE INVENTION

Endovascular grafts have been developed to treat patients with arteriallesions, particularly, aneurysms, trauma and arterial dissections, fromwithin the arterial tract to reduce morbidity and mortality associatedwith the arterial disorder. Application of the graft is typicallyperformed in conjunction with a minimally invasive operative procedureto minimize patient trauma, recovery time, etc.

A variety of endovascular grafts are currently on the market or inclinical trails. These grafts have a number of different characteristicsrelated to their fixation mechanisms, construction and support withrespect to the vessel wall. Currently, fixation of the endovasculargraft can be achieved through radial wall tension using a self expandingstent or by balloon expansion of a deformable stent which may possessfixation elements to penetrate the arterial wall. Alternatively, thestent/graft may be secured to the vessel wall through suturing.

U.S. Pat. No. 4,787,899 to Lazarus discloses an intralumenal graftingsystem for placement of a hollow graft in a corporal lumen. The '899system incorporates a cylindrically shaped graft having a plurality ofhook-like staples embedded in the graft. Once the graft is positionedwith the desired location in the vessel, an inflation member is expandedto drive the staple legs through the vessel wall thereby securing thegraft to the vessel wall.

However, known graft deployment systems such as the type disclosed inthe '899 patent are subject to several disadvantages which detract fromtheir usefulness in vascular graft securement. Graft migrationsubsequent to deployment and leakage about the staple-vessel walljuncture, sometimes in the order of 20-30%, are typical with suchsystems. In addition, the graft with fixed staple arrangement isdeficient in conformational changes which may occur after grafting. Withmodular grafts, i.e., multiple element grafts connected to each other,late disruption at the connection between the components is alsoprevalent.

SUMMARY OF THE INVENTION

Accordingly, the present invention is directed to a system and methodwhich overcomes the disadvantages of the prior art by substantiallyminimizing graft dislodgement and leakage associated with the fixationmechanism. In one preferred embodiment, an apparatus for facilitatingsecurement of a vascular graft within a blood vessel includes a shaftdimensioned for passage within a blood vessel, an expansion membermounted to the shaft and being movable between a contracted conditionand an expanded condition, and a fastener array comprising at least onefastener disposed about a peripheral portion of the expansion member.The one fastener is deployable into a wall of the blood vessel uponmovement of the expansion member to the expanded condition thereof, tothereby engage the vascular graft to secure the vascular graft to theblood vessel wall. The fastener array may include a plurality offasteners positioned to define a substantially annular configurationwhereby the fasteners are arranged about the periphery of the expansionmember. The fasteners may be operatively connected to each other andreleasably secured to the periphery portion of the expansion memberwith, e.g., an adhesive and are preferably released from each otherafter they are deployed. In accordance with an alternate embodiment, thefasteners of the fastener array are connected to a biocompatible memberwhich is mounted about the periphery of the expansion member. Thebiocompatible member may be a biocompatible tape to which the fastenersare adhered. The fasteners of the fastener array may each be a surgicalstaple having a base and penetrating legs extending from opposed ends ofthe base. Preferably, the legs of each staple define a length sufficientto penetrate through the vascular graft and lodge within the bloodvessel wall without penetrating completely through the blood vesselwall.

In another alternate embodiment, the apparatus includes an elongatedshaft dimensioned for passage within a blood vessel, an expansion membersupported at a distal end of the elongated shaft and being adapted toexpand from a substantially contracted condition to a substantiallyexpanded condition, and a surgical staple array including a plurality ofsurgical staples arranged about a peripheral portion of the expansionmember. At least first and second adjacent surgical staples of thestaple array are arranged in partial overlapping relation. The staplesare deployable into a wall of a blood vessel upon expansion of theexpansion member to the expanded condition thereof. Thus, when theexpansion member and the surgical staple array are positioned within asubstantially tubular graft disposed within the blood vessel, theexpansion member is expanded to the expanded condition to deploy thesurgical staples thereby causing engagement of the surgical staples withthe vascular graft and the blood vessel wall to secure the vasculargraft within the blood vessel.

A method for securing a vascular graft within a blood vessel is alsodisclosed. The method includes the steps of accessing a blood vessel;positioning a vascular graft at a predetermined location within theblood vessel; introducing a fastener array including a plurality ofsurgical fasteners arranged about a longitudinal axis of the fastenerarray within the blood vessel and moving the fastener array within theblood vessel to a position at least partially disposed within thevascular graft; and deploying the surgical fasteners of the fastenerarray radially outwardly relative to the longitudinal axis wherebypenetrating portions of the surgical fasteners penetrate the vasculargraft and engage a wall of the blood vessel without completelypenetrating through the blood vessel wall, to thereby secure thevascular graft to the blood vessel wall. The vascular graft may be asubstantially tubular vascular graft defining an outer peripheral graftwall. The surgical fasteners of the fastener array are arranged withrespect to each other to define a substantially annular configurationwhereby, during the step of deploying, the surgical fasteners secure thesubstantially tubular graft to the blood vessel substantially along theouter peripheral graft wall.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the present invention are described herein withreference to the drawings wherein:

FIG. 1 is a view of the system for fixation of an endovascular graft inaccordance with the principles of the present invention;

FIG. 2 is an enlarged side plan view of the distal end of theintralumenal catheter apparatus of the system of FIG. 1 illustrating thecatheter balloon and staple array mounted to the catheter balloon;

FIG. 3 is a schematic cross-sectional view illustrating the annulararrangement of the staple array about the catheter balloon;

FIG. 4 is a view of a preferred staple of the staple array;

FIGS. 5A-5L illustrate various alternate embodiments of the staple ofFIG. 4;

FIG. 6 is a schematic cross-sectional view similar to the view of FIG. 3illustrating the catheter apparatus positioned within a vascular graftdisposed in a blood vessel;

FIG. 7 is a side cross-sectional view further illustrating the catheterapparatus positioned within the vascular graft;

FIG. 8 is a view similar to the view of FIG. 6 illustrating the outertube of the catheter apparatus in a retracted position to expose thestaple array;

FIG. 9 is a view similar to the view of FIG. 8 illustrating expansion ofthe catheter balloon;

FIG. 10 is a view similar to the view of FIG. 9 illustrating the staplesof the staple array deployed in the vessel wall;

FIGS. 11A-11G are schematic views illustrating alternate embodiments ofthe staple array of FIG. 3;

FIG. 12 is a schematic view illustrating an alternative embodiment ofthe staple array incorporating a telescoping staple arrangement;

FIG. 13 is a schematic view illustrating the staple array of FIG. 12deployed within the blood vessel wall;

FIG. 14 is a schematic view illustrating another alternative embodimentof the staple array incorporating a biodegradable tape to which thestaples are secured;

FIG. 15 is a schematic view illustrating the staple array of FIG. 14deployed within the blood vessel wall;

FIG. 16 is a perspective view illustrating another alternate embodimentincluding a stent and a plurality of biodegradable tapes with associatedstaples secured thereto;

FIG. 17 is a view illustrating the stent and array mounted to the distalend of the catheter and inserted within the blood vessel;

FIG. 18 is a view illustrating retraction of the outer tube of thecatheter apparatus to deploy the stent and staple array;

FIG. 19 is a side plan view of an alternate apparatus incorporating anumbrella mechanism for deployment of the staples for fixation ofvascular grafts;

FIGS. 20A-20C are views illustrating a sequence of operation fordeploying the umbrella mechanism; and

FIG. 21 is a schematic cross-sectional view illustrating the catheterapparatus positioned within a vascular graft and the umbrella mechanismfully deployed to drive the staples into the vascular wall.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The preferred embodiments of the apparatus and method disclosed hereinare discussed in terms of repair of a blood vessel wall with applicationof a vascular graft, preferably, an endovascular graft. The preferredembodiment has particular application in treating vascular lesions suchas aneurysms. It is envisioned, however, that the disclosure isapplicable to a wide variety of procedures where a graft prosthesis isutilized to repair or support a vessel wall. In addition, it is believedthat the present apparatus and method finds application in both open andminimally invasive procedures.

The following discussion includes a description of a system utilized inapplication of a vascular graft followed by a description of thepreferred method for securing the graft within a vascular body utilizingthe system.

In the discussion which follows, the term proximal, as is traditional,will refer to the portion of the system which is closest to the operatorwhile the term distal will refer to the portion which is furthest fromthe operator.

Referring now to the drawings in which like reference numerals identifysimilar or identical elements throughout the several views, FIG. 1illustrates the system for deployment of a vascular graft in accordancewith the principles of the present disclosure. The system isparticularly intended to be used in conjunction with a minimallyinvasive procedure wherein access to the operative site is limited orinaccessible by means of conventional techniques. System 100 includescatheter apparatus 200 and a staple array 300 mounted to the catheterapparatus 200. Generally, catheter 200 includes handle 202, elongatedcatheter shaft 204 extending distally from the handle 202 and catheterballoon 206 mounted at the distal end of the catheter shaft 204.Catheter shaft 204 is generally preferably flexible to follow thetortuous path through the body vessel and has a distal blunt end 208 tominimize the potential of undesired penetration into tissue.

Catheter balloon 206 is preferably inflatable between a non-expandedcondition and an expanded condition. Catheter balloon 206 may befabricated from any conventional balloon material such as thermoplasticelastomers, polyethylene terephthalate (PET), ethylene-butylene-styreneblock copolymers, etc. An inflation port 210 adjacent handle 202 permitsintroduction of inflation fluids into catheter 200 to inflate catheterballoon 206. Inflation port 210 is in fluid communication with aninflation lumen extending through catheter shaft 204 and terminating incatheter balloon 206. Alternatively, catheter balloon 206 may bereplaced with a mechanical expanding member which expands and contractsupon movement of corresponding mechanical elements. Apparatiiincorporating such mechanical expansion means suitable for use with thesystem of the present invention are disclosed in U.S. Pat. No. 5,855,565to Bar-Cohen et al. and U.S. Pat. No. 5,507,269 to Marin, the contentsof each disclosure being incorporated herein by reference. As a furtheralternative, the expansion member may be a self expanding stent with thestaples 206 mounted to/on the stent. Expansion of the stent occurs inresponse to temperature changes, e.g., upon exposure of the stent tobody temperature.

As best depicted in FIG. 2, catheter 200 may further include an outertube 212 coaxially mounted about catheter shaft 204. Outer tube 212 isadapted to reciprocally longitudinally move relative to catheter shaft204 (in directions A and B depicted in FIG. 2) between an advancedposition enclosing staple array 300 and a retracted position at leastpartially exposing the staple array. In FIG. 2, outer tube 212 is shownin the retracted position. In one arrangement, catheter tube 212 slidesbetween the two positions via a push/pull motion on the proximal end ofthe catheter tube 212. A handle 214 represented schematically in FIG. 1may be positioned adjacent the proximal end of catheter shaft tofacilitate the desired longitudinal movement. Other means foreffectuating movement of outer tube may be readily appreciated by oneskilled in the art.

With reference now to FIGS. 2-4, staple array 300 of the system includesa plurality of staples 302 circumferentially mounted about catheterballoon 206 with a first staple set 302 p adjacent the proximal end ofthe balloon and a second set 302 d adjacent the distal end. Thepreferred staple 302 includes staple base 304 and staple legs 306extending from opposed ends of the staple base 304. Staple base 304defines an arcuate shape to preferably generally correspond to the outerdimension of catheter balloon 206. Staple legs 306 preferably define alength sufficient to penetrate the graft and enter the blood vessel wallwithout completely piercing the vessel wall, the significance of whichwill be appreciated from the description hereinbelow. Staple legs 306may further possess a retaining element or hook 308 (FIG. 3) dependinginwardly from each leg 306. Retaining hook 308 is advantageouslydimensioned to securely engage the vessel wall and minimize thepotential of staple 302 releasing from the wall subsequent todeployment. The overall size of the staples will depend on the number ofstaples to be used and the particular application. Staples arepreferably made from a biocompatible material such as titanium,stainless steel, thermoplastics, etc and are characterized by possessinggood wear and physical properties such as strength, flexibility anddegradation.

As best depicted in FIGS. 2-3, staple array 300 defines an annular orcircular arrangement about the periphery of catheter balloon 206. In onepreferred embodiment, staples 302 are arranged in juxtaposed, i.e., sideby side relation, with no overlapping of adjacent staples 206. Staples302 are connected to each other preferably along the outer surfaces ofthe adjacent staple bases 304 and/or legs 306 to define the ring-likeconfiguration. An adhesive, preferably, a biodegradable adhesive such ashyaluronic acid, may be utilized to connect the staples to define thearray.

Staple array 300 is positioned about catheter balloon 206 with staplelegs 306 extending radially outwardly relative to the axis “a” ofcatheter shaft 204. With this arrangement, staple legs 306 arepositioned to engage the graft “g” and to extend within the body vesselto which the graft is placed. Preferably, staple array 300 is adhered tothe outer surface of catheter balloon 206, e.g., the outer surface ofstaple base 304 of each staple 302 may be coated with the adhesive(e.g., hyaluronic acid) and mounted to the outer surface of the catheterballoon 206. The annular array of staples 302 as connected through theuse of an adhesive in conjunction with adhesion of the array to theouter surface of the catheter balloon 206 stabilizes the array andensures movement of the staple legs 306 in a general outward radialdirection upon expansion of the catheter balloon 206 therebyfacilitating engagement with the graft and positive fixation withrespect to the vessel wall. The annular side by side arrangement ofstaples 302 at both the proximal and distal ends of catheter balloon 206ensures that the vascular graft is securely attached at both ends to theinterior of the vessel wall.

FIGS. 5A-5L illustrate alternative embodiments of the staple of FIG. 4suitable for use with the system of the present invention. For example,the staple of FIG. 5A is substantially similar to the staple of FIG. 4,but, further includes a wide arc base 310 which engages a greatersurface area of the graft and serves to further stabilize the staplewith respect to catheter balloon 206 upon which it is mounted.Alternatively, the staple may have a curved rectangular base 312 or acurved cylindrical base 314 as depicted in FIGS. 5B, 5C, respectively.FIG. 5D illustrates a further alternative having a telescopic base 316with a plurality of multiple cylindrical portions 318 coaxially arrangedabout the axis of the base. Upon deployment, the cylindrical portions318 extend outwardly to circumscribe the inner wall of the body vessel.An embodiment incorporating a telescopic staple arrangement will bediscussed in further detail hereinbelow. FIG. 5E details a conventionalstaple 320, i.e., C-shaped, which may be utilized with the system of thepresent invention. FIG. 5F is similar to the staple of FIG. 5E, but,further includes inclined hooks 322 on each of the staple legs obliquelyarranged and depending inwardly towards the central area of the base ofthe staple. The hooks 322 function in a similar manner to theircorresponding counterparts of FIG. 4. FIG. 5G illustrates a staple witharrow shaped hooks 324 at the ends of the staple legs which facilitatepenetration through the vascular graft and vessel wall. FIG. 5Hillustrates a staple with helical shaped hooks 326 which penetrate andfacilitate retention of the staple within the vessel wall. FIG. 5Iillustrates a staple with curved staple legs 328 while FIG. 5Jillustrates a staple with multiple hooks 330. It is also envisioned thata plurality of multiple legs 306 (e.g. 4) may be incorporated within thestaple as disclosed in FIG. 5K. FIG. 5L shows a staple with a foldedstem 332. It is further appreciated that the staples may be replacedwith other surgical fasteners including surgical tacks, nails, clips,etc.

Operation of the Apparatus

Referring now to FIGS. 6-10, operation of the system for securing anaortic graft within the aorta for treating an aortic aneurysm will bediscussed. Preferably, the aortic aneurysm is accessed percutaneouslythrough the femoral artery and the aortic graft is placed within theaneurysm. The graft is preferably fabricated from apolytetrafluoroethylene (PTFE) or polymer material as is known in theart. Preferably, the graft may be a stent/graft combination having anexpandable stent and a graft coaxially positioned about the stent. Theexpandable stent may be self expanding or, optionally, a mechanicallydeformable stent such as the type disclosed in U.S. Pat. No. 6,774,328to Cragg, the contents of which are incorporated herein by reference.

With particular reference to FIGS. 6-7, graft “g” (including a stent “s”embedded therein) is first positioned within the aneurysm site “l” ofthe blood vessel “v” by conventional means. Thereafter, catheterapparatus 200 is advanced through the femoral artery to the aneurysmsite “l”. Catheter 200 may be advanced with the assistance of a guidewire as is known in the art and manipulated to the desired location.Preferably, outer tube 212 of catheter 200 is in its advanced positionas depicted in FIG. 7 enclosing staple array 300 (shown in phantom)thereby preventing inadvertent engagement of the staples 302 with thevessel wall during advancement. Catheter apparatus 200 is positionedwithin the graft “g” such that the proximal and distal staple sets 302p, 302 d mounted to catheter balloon 206 are adjacent respective endportions of the graft “g”. Upon reaching the desired location inside theblood vessel “v”, a clamp or other means may be used to prevent furtherforward or upstream movement of the catheter 200. Thereafter, outer tube212 is retracted to the position of FIG. 2 to expose staple array 300.FIG. 8 also schematically depicts in cross-section, outer tube 212retracted to expose the staple array 300.

With reference now to FIGS. 9-10, catheter balloon 206 is expanded fromits initial position to its expanded condition through the introductionof injection fluids as previously discussed. Upon expansion, staple legs306 of staples 302 are driven through the graft “g” to penetrate thevessel wall “v” without completely piercing the wall as depicted in FIG.10. FIG. 10 depicts the catheter balloon 206 removed and staple array300 deployed within the vessel wall “v”. As appreciated, retaining hooks308 of staple legs 306 facilitate retention of the staples 302 withinthe wall “v”. Thereafter, catheter balloon 206 is deflated. Upondeflation, staple bases 304 of staples 302 are released from theiradhesive mounting to catheter balloon 206. Catheter 200 is then removedfrom the vessel leaving the secured graft within the blood vessel “v”.

It is appreciated that staples 302 may be deployed sequentially, e.g.,with the distal staple set 302 d deployed first followed by deploymentof the proximal staple set 302 p. In accordance with this method, outertube 212 may be initially retracted to expose the distal staple set 302d and the catheter balloon 206 inflated to embed the distal staple set302 d in the vessel wall “w”. Thereafter, outer tube 212 may be fullyretracted to expose the proximal staple set 302 p and the catheterballoon 206 inflated to deploy the staples 302. It is further envisionedthat the stent/graft device may be mounted to catheter balloon 206 priorto introduction of the catheter 200 into the blood vessel. In thisapplication, staple legs 306 of staples 302 penetrate the stent/graft tosecure the stent/graft on catheter balloon 206 and outer tube 212encloses the graft “g” during insertion through the body vessel “v”.Inflation of catheter balloon 206 expands the stent/graft (in the caseof mechanically deformable stents) and simultaneously embeds the staplelegs within the vessel wall “v”.

ALTERNATIVE EMBODIMENT(S)

With reference now to FIGS. 11A-11G, it is envisioned that variousmultiple arrays of staples may be used in the system of the presentinvention. For example, FIG. 11A schematically depicts the use of twostaples 350 which could be mounted on catheter balloon 206 in opposedrelation as shown. In the embodiment of FIG. 11B, four staples 350having staple legs 352 are preferably arranged in a circular side byside fashion around the catheter balloon 206. FIGS. 11C-11D illustratethe use of 6 and 8 staples respectively. In accordance with theseembodiments, the additional staples would be arranged in superposedrelation as shown along first and second diagonals “d1, d2”. With theembodiment of FIG. 11D, two circular arrays of four staples each wouldbe arranged in superposed relation to define the annular array. FIG. 11Eillustrates a four staple array 350 that may be mounted on catheterballoon in which adjacent ends of the staples overlap. FIG. 11F issimilar to the embodiment of FIG. 11E but adds an additional two staplesarranged along a diagonal “d1” thereby totaling six staples. FIG. 11Gillustrates a further alternate embodiment of FIG. 11F adding anadditional two staples along diagonal “d2” to total eight staples. Thenumber and arrangement of the staple arrays will depend on the size andintended application of the graft. Preferably, the staples of theaforedescribed arrays are adhered to each other through the use of anadhesive as discussed hereinabove to form a single unit which issubsequently adhered to catheter balloon 206. The overlapping arrayarrangement will provide for more closely spaced staples when deployedwithin the body vessel.

FIGS. 12-13 illustrate another alternative embodiment incorporating atelescopic staple array 370. In accordance with this embodiment, eachstaple 372 of the annular array 370 includes a staple base 374 having aplurality of hollow telescoping members 376 arranged in telescopicrelation. As depicted in FIG. 13, the telescoping members 376 extendoutwardly from their telescopic arrangement upon expansion of catheterballoon 206 (not shown) to drive staple legs 378 into the vessel wall“w”. The telescoping members 376 of each respective staple 370 areoperatively connected to each other to permit such telescoping movementwhile maintaining connection between the members 376. Adjacent staples372 are connected to each other along respective base members 374 withconventional means, e.g., bolt, hook, etc. . . . The staple array 370may be adhered to the outer surface of catheter balloon with an adhesiveas previously discussed.

With reference now to FIG. 14, another embodiment of the staple arrayfor use with the system of the present invention is illustrated. Tapeand staple array 400 includes a thin biodegradable/bioabsorbable polymertape 402 defining a ring-like configuration as shown to which thestaples 302 are attached. Examples of a suitable polymer tape includetapes fabricated from a polyglycolide and/or copolymers thereof. Thestaple base 304 of each staple may be adhered to polymer tape 402 withhyaluronic acid. The number and size of the staples as well as thediameter of the polymer tape 402 can be selected, as required. Thepolymer tape 402 is thin and flexible such that the staples 302 areassembled in the compact circular array as described above and may beadhered to catheter balloon 200. The entire assembly is positioned oncatheter balloon 206 and deployed through expansion of catheter balloon206. FIG. 15 illustrates the location of tape 402, staples 302, andgraft “g” inside the blood vessel “v” after deployment. The ring shapeof tape 402 maintains the staples in the appropriate position to engageand penetrate the vessel wall. The biodegradable/bioabsorbable polymertape disintegrates over a period of time. The absorption rate of thepolymer tape can be controlled through conventional means as appreciatedby one skilled in the art.

FIGS. 16-18 illustrate an alternative embodiment utilizing the staplearray 400 of FIGS. 14-15. In particular, stent and staple array device500 includes a self-expanding stent 502 and a plurality of tape andassociated staple arrays 400 disposed along the outer surface of thestent 502 at predetermined intervals. Stent 502 may be of the typedisclosed in U.S. Pat. No. 6,019,778 to Wilson et al., the contents ofwhich are incorporated herein by reference, and may be temperatureresponsive to assume its enlarged diameter upon deployment and exposurewithin the body vessel. Alternatively, stent 502 may be mechanicallyconstrained in a reduced diameter condition whereby, upon release, thestent returns to its normal unstressed condition. A stent suitable forthis use is disclosed in U.S. Pat. No. 6,165,200 to Lau, the contents ofwhich are incorporated herein by reference. FIGS. 17-18 illustrate useof the device 502 with catheter 200. The device 500 may be mounted tothe distal end of the catheter by conventional mechanical means, e.g., afriction fit. Preferably, the deployment catheter 200 has an outer tube212 which longitudinally reciprocally moves in the same manner asdiscussed in connection with the embodiment of FIG. 1. Upon initialinsertion within the blood vessel “v”, the outer tube 212 is in itsadvanced position enclosing the device 500. When the device 500 isappropriately positioned within the graft “g”, the outer tube 212 isretracted to enable the self-expanding stent 502 to expand sequentiallyto its expanded condition. FIG. 15 illustrates the outer tube 212retracted to an intermediate position and FIG. 16 illustrates the outertube at its fully retracted position. Upon expansion of the respectivesegments of the stent 502, the staples 302 of array 400 are driventhrough the graft “g” and embedded within the wall of the body vessel“v”.

FIGS. 19-21 illustrate an alternate apparatus for deploying a vasculargraft. This apparatus 600 includes a catheter apparatus similar to theapparatus utilized in FIG. 1, but further incorporates an umbrellamechanism 602 for deploying the staples. The umbrella mechanism 602involves a plurality of arms (spokes) 604 having respective proximal 604a and distal legs 604 b connected to each other about a respective hingeschematically identified by reference numeral 606. In FIG. 19, umbrellamechanism 602 is shown confined within outer sheath 603 of catheter 600.A stationary central elongated member 608 extends through the catheter.The elongated member 608 may function as a guide wire and may possess acoiled end 609 as depicted in FIG. 19. The distal legs 604 b of each arm604 are connected to the central member 608 through hinge means, pivotmeans 610, etc. A drive member 612 is coaxially mounted about centralmember 608 and reciprocally moveable along the central member 608. Thedrive member 612 is operatively connected to proximal legs 604 a ofspokes 604 through hinge means 614, (or a pivot pin, etc.) asappreciated by one skilled in the art. The drive member 602 has handle614 disposed at its proximal end adapted for engagement by the user.Drive member 612 moves between a proximal position corresponding to anon-deployed condition of the umbrella mechanism (FIG. 20A) through anintermediate position corresponding to a partially deployed condition ofthe umbrella mechanism (FIG. 20B) to a fully advanced positioncorresponding to a fully deployed condition of the umbrella mechanism(FIG. 20C).

Staples 616 are attached to the surface of the arms of the deviceadjacent hinge 606 with a glue, such as hyaluronic acid or mechanicalinterlocking as discussed in the prior embodiments. The staples 616 canbe arranged in a compact assembly. Before deployment, the arms 604 ofthe umbrella mechanism are aligned to the axis and thus the device withthe staples defines a reduced profile is compact perpendicular to thegraft. FIG. 19 shows the device inside catheter sheath 603 beforedeployment of the staples. FIGS. 20A-20C illustrate the method ofdeployment of the staples. In these Figures, the graft is not shown. Thecatheter 600 is positioned at the desired location inside the bloodvessel (after deployment of the vascular graft). The umbrella mechanism604 is deployed from the outer catheter sheath 603 of the catheter bycausing relative movement of the catheter sheath 603 with respect tocentral member 608 and drive member 612. For example, catheter sheath603 may be retracted to expose umbrella mechanism 604. While maintainingcentral member 608 stationary, drive member 612 is advanced to driveumbrella arm outwardly. The arms of the device are pushed to deploy thestaples in the radical direction (the force on the device are pushed todeploy the staples in the radial direction (the force on the device canbe easily controlled). 3) As depicted in FIG. 21, the staple stems aredriven through the graft and inside the blood vessel, once fixed insidethe vessel wall, the arms are retracted back to the original position.FIG. 21 shows a side view of the umbrella device and the staplesembedded inside the blood vessel.

Thus, the present invention provides a more effective system forpositively securing vessel grafts within a body vessel. The annularstaple arrays ensure fixation about the entire circumference of thegraft. Moreover, the embedded characteristic of the staples of eacharray without penetrating through the vessel wall further reduces thepotential for leakage at the fixation locations.

While the above description contains many specifics, these specificsshould not be construed as limitations on the scope of the disclosure,but merely as exemplifications of preferred embodiments thereof. Thoseskilled in the art will envision many other possible variations that arewithin the scope and spirit of the invention

1. An apparatus for securing a vascular graft within a blood vessel, theapparatus comprising: a shaft dimensioned for passage within the bloodvessel and having an expansion member, said expansion member movablebetween a contracted condition and an expanded condition; and a fastenerarray comprising a plurality of fasteners disposed about a peripheralportion of said expansion member, said plurality of fasteners beingdeployable into a wall of said blood vessel upon movement of saidexpansion member to said expanded condition thereof, to engage and tosecure the vascular graft to the wall of the blood vessel, wherein, whenthe expansion member is in the contracted condition, fasteners of thefastener array are arranged in overlapping relation.
 2. The apparatusaccording to claim 1, wherein each fastener of the plurality offasteners has a telescopic base.
 3. The apparatus according to claim 1,wherein each fastener of the fastener array is operatively connected toanother fastener.
 4. The apparatus according to claim 1, wherein saidfasteners of said fastener array are releasably secured to saidperipheral portion of said expansion member.
 5. The apparatus accordingto claim 4 wherein the fasteners are releasably adhered to saidperipheral portion of said expansion member with an adhesive.
 6. Theapparatus according to claim 2 wherein said fastener array defines asubstantially annular arrangement whereby said fasteners are arrangedabout a periphery of said expansion member.
 7. The apparatus accordingto claim 1 wherein said fasteners of said fastener array are connectedto a biocompatible member, said biocompatible member being mounted aboutsaid peripheral portion of said expansion member.
 8. The apparatusaccording to claim 7 wherein the biocompatible member is a biocompatibletape.
 9. The apparatus according to claim 2, wherein the telescopic baseof the fasteners permits telescoping movement while maintainingconnection between adjacent fasteners of said fastener array whensecuring the graft.
 10. The apparatus according to claim 1, wherein eachfastener of said fastener array is a surgical staple having a base andpenetrating legs extending from opposed ends of said base.
 11. Theapparatus according to claim 10 wherein said legs of each said stapledefine a length sufficient to penetrate through the vascular graft andlodge within the wall of the blood vessel without penetrating completelythrough the wall of the blood vessel.
 12. The apparatus according toclaim 1 wherein said expansion member is an inflatable balloon member.13. The apparatus according to claim 1, wherein the expansion member isan umbrella mechanism.
 14. The apparatus according claim 10, whereinprogressive balloon inflation provides sequential deployment of thefasteners.
 15. An apparatus for securing a vascular graft within a bloodvessel, the apparatus comprising: an elongated shaft having proximal anddistal ends, and defining a longitudinal axis, said elongated shaftbeing dimensioned for passage within the blood vessel; an expansionmember supported at said distal end of said elongated shaft, saidexpansion member movable between contracted and expanded conditions; anda surgical staple array including a plurality of surgical staplesarranged about a peripheral portion of said expansion member, aplurality of surgical staples being arranged in partial overlappingrelation, said staples of said staple array being deployable into a wallof the blood vessel upon expansion of said expansion member; wherein,when said expansion member and said surgical staple array are within thegraft positioned within the blood vessel, said expansion member expandsto deploy said surgical staples, thereby engaging said surgical stapleswith the vascular graft and the blood vessel to secure the vasculargraft within the blood vessel.
 16. The apparatus according to claim 15,wherein expansion of the expansion member arranges said surgical staplesof said staple array to define an annular configuration.
 17. Theapparatus according to claim 16 wherein the plurality of surgicalstaples are, when the expansion member is in the contracted condition,positioned in a superposed, compacted relation wherein adjacent ends ofsaid the surgical staples overlap.
 18. A method for securing a vasculargraft within a blood vessel, the method comprising the following steps:accessing the blood vessel; positioning the vascular graft at apredetermined location within the blood vessel; introducing and moving afastener array within the blood vessel, said fastener array including aplurality of surgical fasteners arranged about a longitudinal axis ofsaid fastener array, said surgical fasteners having penetrating portionsdimensioned to penetrate the vascular graft; and deploying said surgicalfasteners of said fastener array radially outwardly relative to saidlongitudinal axis, wherein moving the fastener array within the bloodvessel position disposes the fastener array at least partially withinthe vascular graft, and ends of said fasteners are overlapped prior todeploying said fastener array to provide a compacted fastenerarrangement, said penetrating portions of said surgical fastenerspenetrate the vascular graft and engage the blood vessel withoutcompletely penetrating the blood vessel, to thereby secure the vasculargraft of the blood vessel.
 19. The method according to claim 18, whereinsaid surgical fasteners of said fastener array are arranged with respectto each other to define a compacted substantially annular configurationwhereby, upon deploying, said surgical fasteners expand and secure thesubstantially tubular graft to the blood vessel substantially along anouter peripheral graft wall.
 20. The method according to claim 18,wherein said fasteners are sequentially deployed by an expansion membercausing said surgical fastener to move radially outwardly intoengagement through the vascular graft and into the blood vessel.